invitro_spain
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21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company
Hello all!
I have a silly question. We are an `In vitro´ medical device European company and I am going to prepare the 21 CFR 820 documents to Export to USA. We have the ISO 13485 certificate since 2009. All the Quality system documents and records are in spanish.
Must I prepare all documents and records in English for a future FDA inspection?
I don´t know how to do it. I´m afraid I have to maintain to QS in my company to do the same things.
Can anybody helps?
Thank you
Hello all!
I have a silly question. We are an `In vitro´ medical device European company and I am going to prepare the 21 CFR 820 documents to Export to USA. We have the ISO 13485 certificate since 2009. All the Quality system documents and records are in spanish.
Must I prepare all documents and records in English for a future FDA inspection?
I don´t know how to do it. I´m afraid I have to maintain to QS in my company to do the same things.
Can anybody helps?
Thank you